Naratriptan is indicated for the acute treatment of migraine attacks with or without aura in adults.

1 mg white to off-white round, biconvex tablet debossed with “54” on one side and “227” on the other side.

2.5 mg white to off-white round, biconvex tablet debossed with “54 351” on one side and plain on the other side.

Naratriptan is contraindicated in patients with:

The following adverse reactions are discussed in more detail in other sections of the prescribing information:

Adverse reactions observed after overdoses of up to 25 mg included increases in blood pressure resulting in lightheadedness, neck tension, tiredness, and loss of coordination. Also, ischemic ECG changes likely due to coronary artery vasospasm have been reported.

The elimination half-life of naratriptan is about 6 hours

Naratriptan Tablets, USP contains naratriptan hydrochloride, USP, a selective 5-HT

The empirical formula is C

Each naratriptan tablet for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose (anhydrous), magnesium stearate, and microcrystalline cellulose.

The efficacy of naratriptan in the acute treatment of migraine headaches was evaluated in 3 randomized, double-blind, placebo-controlled trials in adult patients (Trials 1, 2, 3). These trials enrolled adult patients who were predominantly female (86%) and Caucasian (96%) with a mean age of 41 years (range: 18 to 65 years). In all studies, patients were instructed to treat at least 1 moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed up to 4 hours after dosing. Associated symptoms such as nausea, vomiting, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours postdose. A second dose of naratriptan or other rescue medication to treat migraines was allowed 4 to 24 hours after the initial treatment for recurrent headache.

In all 3 trials, the percentage of patients achieving headache response 4 hours after treatment, the primary outcome measure, was significantly greater among patients receiving naratriptan compared with those who received placebo. In all trials, response to 2.5 mg was numerically greater than response to 1 mg and in the largest of the 3 trials, there was a statistically significant greater percentage of patients with headache response at 4 hours in the 2.5-mg group compared with the 1-mg group. The results are summarized in Table 2.

The estimated probability of achieving an initial headache response in adults over the 4 hours following treatment in pooled Trials 1, 2, and 3 is depicted in Figure 1.

Figure : Estimated Probability of Achieving Initial Headache Response Within 4 Hours in Pooled Trials 1, 2, and 3

For patients with migraine-associated nausea, photophobia, and phonophobia at baseline, there was a lower incidence of these symptoms 4 hours following administration of 1-mg and 2.5-mg naratriptan compared with placebo.

Four to 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other rescue medication. The estimated probability of patients taking a second dose or other rescue medication to treat migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2.

Figure : Estimated Probability of Patients Taking a Second Dose of Naratriptan Tablets or Other Medication to Treat Migraine Over the 24 Hours Following the Initial Dose of Study Treatment in Pooled Trials 1, 2, and 3

There is no evidence that doses of 5 mg provided a greater effect than 2.5 mg. There was no evidence to suggest that treatment with naratriptan was associated with an increase in the severity or frequency of migraine attacks. The efficacy of naratriptan was unaffected by presence of aura; gender, age, or weight of the subject; oral contraceptive use; or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers, calcium channel blockers, tricyclic antidepressants). There was insufficient data to assess the impact of race on efficacy.

NDC 0054-0278-03: Bottle of 9 Tablets

NDC 0054-0278-25: Bottle of 100 Tablets

NDC 0054-0279-03: Bottle of 9 Tablets

NDC 0054-0279-25: Bottle of 100 Tablets

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform patients that naratriptan may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech and should ask for medical advice if any indicative sign or symptoms are observed. Apprise patients of the importance of this follow-up

Inform patients that anaphylactic reactions have occurred in patients receiving naratriptan. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens

Inform patients that use of naratriptan within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated

Caution patients about the risk of serotonin syndrome with the use of naratriptan or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors

Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary)

Advise patients to notify their healthcare provider if they become pregnant during treatment or intend to become pregnant

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed

Treatment with naratriptan may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of naratriptan.

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Rx Only

Read this Patient Information before you start taking naratriptan tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Naratriptan is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

Naratriptan is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine headaches.

Naratriptan is not used to prevent or decrease the number of migraine headaches you have.

Naratriptan is not used to treat other types of headaches such as hemiplegic migraines (that make you unable to move on one side of your body) or basilar migraines (rare form of migraine with aura).

It is not known if naratriptan is safe and effective to treat cluster headaches.

It is not known if naratriptan is safe and effective in children younger than 18 years of age.

Ask your healthcare provider if you are not sure if your medicine is listed above.

Before you take naratriptan, tell your healthcare provider about all of your medical conditions, including if you:

Using naratriptan with certain other medicines can affect each other, causing serious side effects.

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

Naratriptan can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

These serious side effects include:

The most common side effects of naratriptan include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of naratriptan. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use naratriptan for a condition for which it was not prescribed. Do not give naratriptan to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about naratriptan. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about naratriptan that is written for healthcare professionals.

For more information call 1-800-962-8364.

Active ingredient: naratriptan hydrochloride, USP

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose (anhydrous), magnesium stearate and microcrystalline cellulose.

This Patient Information has been approved by the U.S. Food and Drug Administration.

The brands listed are registered trademarks of their respective owners.

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